Clinical Operations and TMF Specialist

Full-time Other-General

Keeping clinical trials audit-ready through expert TMF oversight and operational excellence.

R&D Partners is seeking a Clinical Operations and TMF Specialist to support Trial Master File (TMF) operations for clinical trials. This role ensures compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs, maintaining inspection readiness and alignment with trial management strategies.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities

• Initiate study setup in the Clinical Operations system during the start‑up phase.
• Onboard internal and external study team members, ensuring role‑based training and system access.
• Customize study‑specific TMF Plans and TMF Indexes with input from relevant team members.
• Act as the primary contact for training, user support, and adherence to good documentation practices.
• Fulfill the Clinical Bus...